Actively Recruiting
A Phase II Trial of Tarlatamab, a DLL3-targeted Bispecific T-cell Engager, in Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (DeLLight)
Led by Inkeun Park · Updated on 2026-04-13
60
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Inkeun Park
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who previously received platinum-based chemotherapy. This phase 2, open-label, single-arm study targets EPNECs, which are rare and aggressive cancers with limited second-line treatment options. Tarlatamab targets the DLL3 protein, which is highly expressed in these cancers, offering a potential novel therapy for patients with poor prognosis. Participants will receive tarlatamab through intravenous infusions starting with a 1 mg dose on Cycle 1 Day 1, then 10 mg doses on Day 8 and Day 15 of Cycle 1, followed by 10 mg every two weeks thereafter. The study includes two cohorts based on cancer origin: gastrointestinal and pancreaticobiliary, and genitourinary, with identical dosing schedules. There is no placebo group, and treatment continues until disease progression or other criteria. During the study, participants undergo a 21-day screening period followed by treatment and a safety follow-up visit, then long-term follow-up monitoring. Researchers will assess tumor response using RECIST 1.1 criteria and measure outcomes such as objective response rate, progression-free survival, overall survival, and duration of response. Participants receive regular evaluations including imaging scans and clinical assessments to monitor disease status and safety throughout the study period, which may last up to 36 months.
CONDITIONS
Brief Title
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided informed consent before starting any study procedures.
- Age 19 years or older at the time of consent.
- Histologically confirmed relapsed or refractory extrapulmonary neuroendocrine carcinoma.
- Cancers originating from gastrointestinal, pancreaticobiliary, or genitourinary sites.
- Progressed or recurred after one platinum-based chemotherapy regimen.
- Measurable disease per RECIST 1.1 or evaluable by PCWG-3 criteria for prostate cancer.
- ECOG performance status of 0 to 2.
- Minimum life expectancy of 12 weeks.
- Adequate blood, liver, kidney, lung, and heart function as defined by study criteria.
- Provision of tumor tissue samples for central testing.
You will not qualify if you...
- Symptomatic untreated central nervous system metastases or leptomeningeal disease.
- History of severe immune-related adverse events or immune-mediated CNS events.
- Active autoimmune disease requiring recent systemic treatment.
- History of solid organ transplantation.
- Other malignancies within the past 2 years except certain low-risk cancers.
- Recent serious heart conditions or arterial thrombosis within 12 months.
- Active infections including uncontrolled HIV, hepatitis B or C.
- Receiving systemic corticosteroids or immunosuppressive therapy within 7 days prior to treatment.
- Evidence of interstitial lung disease or active non-infectious pneumonitis.
- Prior therapy with tarlatamab or selective DLL3 inhibitors.
- More than 2 prior systemic therapies for EPNEC.
- Recent anti-cancer therapy or major surgery within specified timeframes.
- Use of medications that strongly affect drug metabolism enzymes within specified windows.
- Female subjects who are pregnant, breastfeeding, or unwilling to use contraception.
- Male subjects unwilling to use contraception or abstain from sperm donation.
- Known sensitivity or contraindication to study products.
- Unlikely to comply with study visits or procedures.
- Any other clinically significant medical condition or disorder.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive tarlatamab via intravenous infusion starting with a 1 mg dose on Day 1, followed by 10 mg doses on Days 8 and 15 of the first cycle, then 10 mg every two weeks in subsequent cycles.
Weekly visits during the first 3 weeks, then visits every two weeks thereafter
Duration - Up to 36 months
Participants are monitored for safety after completing treatment.
1 visit (in-person)
Duration - Up to 36 months after the last safety follow-up visit
Participants are observed for overall survival and long-term outcomes.
Periodic visits depending on participant status
Trial Site Locations
Total: 4 locations
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
3
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
4
Yonsei Severance Hospital
Seoul, South Korea
Not Yet Recruiting
Research Team
I
Inkeun Park, M.D, Ph D
H
Hung-Don Kim, M.D, Ph D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here